Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Amgen And AstraZeneca Tout Fresh Tezepelumab Data
Recently-submitted tezepelumab reduced the annualized asthma exacerbation rate by 86% in a subgroup of patients with severe, uncontrolled asthma and nasal polyps, according to data presented at the European Respiratory Society congress.
Takeda Sees Another Wave 1 Plan Come Crashing Down
The Phase III failure for pevonedistat in three rare blood cancer settings is the third setback for Takeda’s Wave 1 pipeline candidates this year. The NEDD8 inhibitor is still being studied in other settings.